Clinical Study to Evaluate the Safety and Efficacy of Candela Technology (NCT06202274) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Clinical Study to Evaluate the Safety and Efficacy of Candela Technology
United States, Israel500 participantsStarted 2023-10-04
Plain-language summary
This is a non-randomized, multi-center, open-label, prospective clinical study evaluating the clinical treatment with Candela Medical Technology.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. At least 18 years of age or older
. Fitzpatrick skin type I-VI
. Willingness to provide signed, informed consent to participate in the study
. Able and willing to comply with the treatment/follow-up schedule and requirements and pre and post treatment instructions.
. Willing to receive clinical treatments with the study device to be utilized and comply with all study (protocol) requirements.
. Willingness to allow photographs and/or video of treated areas, and to release their use for scientific/educational and/or promotional/marketing purposes
. Willing to abstain from any other procedures, medications or topicals in the study treatment areas for the duration of the study which the investigator deems would interfere with the study.
Exclusion criteria
. Pregnant or planning to become pregnant, or breast feeding during the study
. Skin cancer in the treatment area or history of melanoma in the treatment area
. History of current cancer and subject has undergone chemotherapy within the last 12 months
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Numerical Rating Scale (NRS)
Timeframe: From the first treatment to the last treatment, up 132 weeks.
2
Post-treatment Assessment Severity Scale
Timeframe: From the first treatment to the last treatment, up to 132 weeks.
. Severe concurrent conditions, such as cardiac disorders, per investigator discretion
. Impaired immune system or use of immunosuppressive medications as deemed inappropriate per investigator discretion
. Herpes Simplex Virus (HSV) in the intended treatment area unless treated following a prophylactic regimen
. Pacemaker or internal defibrillator or any active electrical implant anywhere in the body if to be treated with an RF based device
. Superficial metal or other implants in the treatment area, except superficial dental implants, unless these implants can be removed or covered with rolled gauze during treatment if to be treated with an RF based device